Comparing two methods of non invasive ventilatory support: nasal contentious positive airway pressure (nCPAP) and nasal intermittent positive pressure ventilation (NIPPV) in preterm infants
This is a randomized clinical trial aimed to compare the efficacy of two non invasive ventilatory support in management of respiratory distress syndrome in preterm infants with Respiratory Distress Syndrome. Sixty six preterm infants with birth weight less than 1500 grams randomly allocate in two groups ( nasal Continuous Positive Airway Pressure and Nasal Intermittent Positive Pressure Ventilation). We evaluate all infants for need to surfactant replacement therapy, the number of surfactant doses and need for intubation and assisted ventilation.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201702063915N19
Registration date:2017-02-15, 1395/11/27
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-02-15, 1395/11/27
Registrant information
Name
Manizheh Mostafa Gharehbaghi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1526 2253
Email address
peirovifara@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Research vice chancellor of Tabriz University of Medical Sciences
Expected recruitment start date
2017-01-10, 1395/10/21
Expected recruitment end date
2017-07-23, 1396/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing two methods of non invasive ventilatory support: nasal contentious positive airway pressure (nCPAP) and nasal intermittent positive pressure ventilation (NIPPV) in preterm infants
Public title
Comparing two methods of non invasive ventilatory support in preterm infants
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Preterm infants with gestation ages 28-32 weeks; birth weight less than 2500 grams; diagnosis of Respiratory distress syndrome (based on clinical signs and radiology); need for ventilatory support
Exclusion criteria:
Congenital malformations; upper airway anomalies; cardiovascular instability;anemia at birth with hemoglobin less than 10gr/dL; intubation at birth
Age
To 30 days old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic Committee of Tabriz University of Medical Sciences
Street address
Golghasht street
City
Tabriz
Postal code
Approval date
2017-01-09, 1395/10/20
Ethics committee reference number
IR.TBZMED.REC.1395.1048
Health conditions studied
1
Description of health condition studied
Respiratory Distress Syndrome
ICD-10 code
P22
ICD-10 code description
سندرم دیسترس تنفسی
Primary outcomes
1
Description
Need for intubation
Timepoint
First 72 hours of birth
Method of measurement
Intubation based on arterial blood gas analysis
Secondary outcomes
1
Description
Need for Surfactant
Timepoint
First 72 hours of birth
Method of measurement
Surfactant adminstration via endotracheal tube
Intervention groups
1
Description
Intervention group receive nasal intermittent positive pressure ventilation from first minutes of birth after admission in neonatal intensive care unit
Category
Treatment - Devices
2
Description
Control group receive nasal continuous positive airway pressure from first minutes of birth after admission in neonatal intensive care unit
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
NICU. Alzahra Hospital
Full name of responsible person
Street address
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Eivasi. M.D.
Street address
Alzahra Hospital
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Ghodratolah Eivasi. M.D.
Position
Subspecicialist Assisstant
Other areas of specialty/work
Street address
Alzahra Hospital
City
Tabriz
Postal code
Phone
+98 41 3553 9161
Fax
Email
dr.eivazi@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Maizheh Mostafa Gharehbaghi.M.D.
Position
Professor
Other areas of specialty/work
Street address
Alzahra Hospital
City
Tabriz
Postal code
Phone
+98 41 3553 9161
Fax
Email
GHAREHBAGHIMM@YAHOO.COM
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)